Kornimate/medical-research-clean huggingface dataset:
cognitive load assessment of helicopter pilots in training

Conditions: Cognitive Impairment; Situational Anxiety; Skills, Coping

Summary: the aim of this study is to identify the effect of the increase of the situation demands, with or without a thread, on military helicopter pilot's cognitive load, depending on their skills acquisition (at the beginning, midway and end of training course). this study is carried out on a simulator, in virtual reality and allows to identify the moments of cognitive load enhancement and the associated indicators such as subjective, physiological and behavioural indicators. recommendations will be done to go towards an individualization of the lessons during the pilots education, by anticipating an overload which has a deleterious effect on learning.


Eligibility criteria:
inclusion criteria: * being a trainee at the instructional center of helicopter crews * being more than 18 years old * being insured under the french social security system * having the bases to pilot helicopters * having signed the non-opposition form exclusion criteria: * being minor or an incapacitated adult * being in a motor handicap situation * having a cardiac pathology * having a visual pathology that is uncorrected by glasses or lens * having a bad audition * having a psychiatric disorder, a neurologic or organic disorder requiring a medical treatment * taking psychotropics * drinking more than 28 units of alcohol per week * being epileptic

Keywords: cognitive load military helicopter pilots
investigating immune mechanisms in atopic eczema

Conditions: Atopic Dermatitis

Summary: the aim of this study is to investigate the mechanisms behind the immune dysfunction that occurs in atopic eczema (or atopic dermatitis).

atopic eczema is a chronic inflammatory skin disease that affects 15-20% of children and 12% of adults and leads to significant loss of quality of life. it results from a complex interaction of genetic and environmental factors, and is characterised by dysregulation of the cutaneous immune system. specifically, in the skin of eczema patients there is a persistence of t lymphocytes (a crucial cell involved in regulating the immune system), and an overproduction of certain cytokines (signalling molecules that are essential in producing inflammatory responses). the study intends to investigate the causes of atopic eczema by examining the number, characteristics and function of t lymphocytes in the skin and the blood of eczema patients, as well as the types of cytokine they produce. to achieve this the investigators aim to take skin biopsies, tissue fluid (from induced skin suction blisters) and blood samples from adult eczema patients and healthy controls for analysis. additionally, in these groups a cutaneous immune response will be initiated by injecting tuberculin protein purified derivative (the mantoux test) into the skin, to further investigate how the behaviour of t lymphocytes varies between eczema patients and healthy controls. this research is important in view of the high prevalence of atopic eczema in the population. an improved understanding of its causes will hopefully lead to more effective treatments for this condition in future.

Eligibility criteria:
inclusion criteria: * history of atopic dermatitis (according to united kingdom working party's diagnostic criteria) * previous bacillus calmette-guerin vaccination exclusion criteria: * unable to give written informed consent * previous history of hypersensitivity to local anaesthetic (for skin biopsy) or tuberculin ppd (for skin test) * pregnancy or breast feeding * history of tuberculosis * recent infection or immunisation (within last month) * known immunodeficiency e.g. hiv infection, primary immunodeficiency, any history of chemotherapy or radiotherapy * systemic steroids within the last month or any other immunosuppressive medications (eg. methotrexate, ciclosporin or azathioprine) within the previous 3 months * phototherapy within the previous 28 days * treatment with potent topical corticosteroids or tacrolimus ointment within the previous 7 days * significant co-morbidity (diabetes, renal failure, liver failure, heart failure) * on warfarin or known bleeding disorder * history of neoplasm in last 10 years (not including basal cell carcinoma) * previous keloid scarring
a study to evaluate the tolerability, safety, and pk of ast-201 in patients with gpc3-positive advanced solid tumors

Conditions: Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Liver Neoplasms

Summary: this is the first in human trial clinical study of ast-201 in patients with gpc3-positive advanced solid tumors. this study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of ast-201 across various tumor types.

ast-201 is a novel aptamer drug conjugate (apdc) investigational agent with demonstrated preclinical efficacy in gpc3-positive tumor models. this phase 1 clinical study aims to investigate the safety, tolerability, and preliminary efficacy of ast-201, targeting gpc3-positive advanced solid tumors. the study consists of two parts: phase 1a and phase 1b. in phase 1a, ast-201 will be administered in a dose escalating manner across cohorts of patients to determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d). in this dose-escalation phase, patients will receive ast-201 as a single agent, with safety, tolerability, and pharmacokinetic (pk) profiles assessed. in phase 1b, patients will receive ast-201 at the rp2d across specific gpc3-positive tumor types to further explore safety and efficacy. this expansion phase focuses on assessing anti-tumor efficacy and overall safety in a broader patient population. data collected from this study will support future clinical development of ast-201 in gpc3-positive advanced solid tumors.

Eligibility criteria:
inclusion criteria * male and female aged ≥19 years * histologically and/or cytologically diagnosed as the advanced recurrent solid tumor * gpc3-positive confirmed by ihc test * at least 1 measurable or non-measurable but evaluable lesion as defined per recist v1.1 (modified recist for hepatocellular carcinoma) * ecog performance status of 0 or 1 * life expectancy at least 12 weeks * adequate hematologic, hepatic, renal, and heart/coagulation function * child-pugh class of a for hcc exclusion criteria * subjects with ischemic heart disease * subjects with anti-tumor treatment within 4 weeks * subjects with comorbidities such as uncontrolled hypertension, heart failure, etc. * pregnant or potentially pregnant and lactating woman

Keywords: glypican-3 (gpc3) gpc3-positive advanced solid tumors ast-201 aptamer-drug conjugate hepatocellular carcinoma (hcc) advanced solid tumors metastatic dose escalation and expansion
hemodynamic effects of physiotherapy in the early postoperative period

Conditions: Physiotherapy; Postoperative; Lung Diseases

Summary: physiotherapy will be applied to the patients who undergo thoracotomy operation after 24 hours of intensive care stay. physiotherapy program includes breathing exercises, incentive spirometer training, ambulation. oxygen saturation, heart rate and blood pressure values will be recorded before and after the training session. changes in the follow-up parameters will be discussed.


Eligibility criteria:
inclusion criteria * between 18-75 age * hemodynamically stable * being conscious exclusion criteria: * excessive pain * neurological complications * posttraumatic and musculoskeletal problems to prevent exercise * do not want to be included in the study * fever above 38 degrees
tad after chemotherapy in locally advanced breast cancer

Conditions: Sentinel Lymph Node; Breast Cancer; Locally Advanced

Summary: this is an observational study to validate target axillary dissection (tad) in locally advanced tumors (cn2 and/or ct4).

the procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (nac) and performing surgery after completing the nac. the tad will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. an initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of tad without associated disease are obtained.

Eligibility criteria:
inclusion criteria: * axillary lymph node metastasis proven by cytology * clinical or radiological n2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis) * extensive t4 subsidiary to axillary lymphadenectomy according to current clinical criteria * neoadjuvant chemotherapy exclusion criteria: * cn3 verified by imaging tests * n2 due to internal mammary involvement (n2b). * tumors whose surrogate molecular subtype is luminal a. * patients undergoing neoadjuvant endocrine therapy * patients with local recurrences and metastatic tumors.
safety and efficacy of bimatoprost solution in treating eyelash loss or hypotrichosis in children

Conditions: Eyelash Hypotrichosis; Alopecia Areata

Summary: this study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.


Eligibility criteria:
inclusion criteria: * children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study * children who have minimal to moderate inadequate eyelashes due to alopecia areata * adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes exclusion criteria: * any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants. * semi-permanent eyelash tint, dye or eyelash extension application within 3 months * use of over the counter eyelash growth products within 6 months. * use of prescription eyelash growth products (eg, latisse®) * any eye condition that would prevent required ophthalmology exams
cafedrin/theodrenalin (akrinor®) versus ephedrine for treatment of hypotension in the peri-operative phase in inpatient setting

Conditions: Hypotension

Summary: this is a national, multicentre, prospective, open, two-arm, non-interventional study with hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension, wherein the patients are assigned to a treatment arm based on the department.


Eligibility criteria:
inclusion criteria: * inpatients, who received iv treatment (bolus administration) with cafedrine/theodrenaline or ephedrine (ephedrin meduna) due to an acute arterial hypotension * consent to use of data is available * patient under careful blood pressure and pulse monitoring (at least 2 minutes measuring interval (bp/hr) and/or at least 7 measurements within the first 15 minutes after the first application of cafedrine/theodrenaline or ephedrine) cohort a: * treatment of hypotension in \ 20% syst. compared to preoperative base value (syst.) * patients ≥ 50 years old * pre-existing comorbidities (asa classification 2-4) * elective surgery * general anaesthesia with propofol/fentanyl ≥ 0.2 mg (or equivalent) cohort b: * treatment of hypotension in \ 10% syst. compared to preoperative base value (syst.) * patients ≥ 18 years old * caesarean section under spinal anaesthesia exclusion criteria: * contraindication to the use of cafedrine/theodrenaline or ephedrine (ephedrin meduna) in accordance with current german specialist information * hypersensitivity to any product ingredient * hypertensive blood pressure readings * mitral stenosis * narrow-angle glaucoma * hyperthyroidism * pheochromocytoma * prostatic adenoma with urinary retention * bronchial asthmatics with sulphite sensitivity * hyper-excitability * arteriosclerosis * aneurysm * treatment with other indirect sympathomimetic drugs (example: phenylpropanolamine, phenylephrine, pseudoephedrine or methylphenidate) * use of monoamine oxidase (mao) inhibitors (including within the last two weeks) * prophylactic administration of cafedrine/theodrenaline or ephedrine or other anti-hypertensives * sepsis, septic shock or systemic inflammatory response syndrome (sirs) cohort a: • intra-cranial surgery or heart surgery cohort b: * high-risk pregnancy (emergency caesarean, severe infantile malformation) * multiple pregnancy * amniotic infection syndrome
alpha-1 foundation research registry

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the alpha-1 foundation research registry is a confidential database made up of individuals diagnosed with severe alpha-1 antitrypsin deficiency (alpha-1) or the carrier state.

the registry was established in 1997 by the alpha-1 foundation to facilitate research initiatives and promote the development of improved treatments and a cure for alpha-1. located at the medical university of south carolina (musc) in charleston, the registry employs procedures that ensure the most stringent confidentiality of participants. the registry operates under the direction of the alpha-1 foundation board of directors and is guided by an advisory committee comprised of leaders in the medical, ethical, scientific and alpha communities. individuals enrolled in the registry have the ongoing opportunity to participate directly in clinical trials of new therapeutic approaches in addition to other research opportunities.

Eligibility criteria:
inclusion criteria: * individuals of all ages who are diagnosed with severe alpha-1 antitrypsin deficiency or the carrier state

Keywords: alpha 1-antitrypsin deficiency
inr tracking coumadin use with phone app

Conditions: Warfarin; Mobile Applications

Summary: this study aims to compare the inr values of the patients followed by face-to-face and telephone applications.

warfarin has a narrow therapeutic window. maintaining the patient's international normalized ratio (inr) within the predefined therapeutic range is one of the main challenges of warfarin treatment. this study was designed as a randomized controlled experiment. twelve patients living in a distant place were assigned to the experimental group, and 12 patients living nearby and followed in the outpatient clinic were assigned to the control group. a patient information form and the adherence to refills and medications scale were used to collect data.

Eligibility criteria:
inclusion criteria: * at least 18 years old, using a smartphone, not having a psychiatric illness or treatment, and agreeing to participate exclusion criteria: * requiring medical examination, not using a smartphone, having a psychiatric illness or treatment, and not agreeing to participate
a novel multiplex elisa assay for evaluating patients with microscopic hematuria for bladder cancer

Conditions: Bladder Cancer

Summary: to improve upon the non-invasive detection of bca by further validating a multiplex elisa assay directed at a bca-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

hematuria is the most common presentation of bca with 8% of patients with microscopic hematuria harboring bca. vuc is the most widely used urine-based assay for detecting bca; however, it fails to detect approximately 50% of low-grade or early stage bca when it is most curable. because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. we propose to improve the non-invasive detection of bca by further validating a multiplex elisa assay directed at a bca-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

Eligibility criteria:
inclusion criteria: * age 18 years or older * have documented or reported microscopic hematuria within 3 month of study enrollment * willing and able to give written informed consent exclusion criteria (participants must not): * have history of bca * history of previous cancer (excluding basal and squamous cell skin cancer) * have a known active urinary tract infection or urinary retention * have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dl) * have ureteral stents, nephrostomy tubes or bowel interposition * have recent genitourinary instrumentation (within 10 days prior to signing consent) * be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
making football safer for women: implementing an injury prevention program

Conditions: Anterior Cruciate Ligament Injuries; Concussion, Brain; Musculoskeletal Injury

Summary: the aim of this study is to determine how we can best support coaches to implement an injury prevention (ip) program (prep-to-play) in female community australian football. we will recruit at least 140 female community football teams from 15 different football leagues in victoria, australia. teams will be competing in u16, u17, u18, u19 or open womens competitions. we will train and support coaches to implement the ip program and evaluate the effects of the ip program on injuries across two football seasons.

primary aim: to compare the impact of supported and unsupported implementation strategies on the use of an ip program (prep-to-play) in female community australian football. secondary aims are to: 1. evaluate the effects of supported implementation of prep-to-play on injury risk reduction. 2. identify barriers and enablers to sustainability of the prep-to-play implementation model, and develop clear recommendations for a future, sustainable national roll out of prep-to-play. 3. evaluate the cost-effectiveness of prep-to-play. primary hypothesis the primary hypothesis is that supported implementation will result in increased use of prep-to-play in female community australian football compared to unsupported implementation. secondary hypotheses the secondary hypotheses are that the supported implementation of prep-to-play will: * result in a reduction of anterior cruciate ligament (acl) injuries in females participating in community australian football; * result in a reduction of other musculoskeletal injuries and concussion among females participating in community australian football; * be more cost-effective than the unsupported implementation.

Eligibility criteria:
inclusion criteria * coach consents to be trained and to implement prep-to-play * team includes players aged 13 years and above registered to play community football * the team trains at least once per week in addition to match-play * coach has at least level i coach accreditation (or enrolled to be accredited in 2021) exclusion criteria: * inability to understand written english * players aged less than 13 years

Keywords: injury prevention implementation football female
a multiple dose study of pf-04950615 (rn316) in subjects on maximum doses of statins

Conditions: Hypercholesterolemia; Dyslipidemia

Summary: pf-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower ldl cholesterol.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18.5 to 40 kg/m2 * on a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to day 1. * lipids meet the following criteria twice during screening period: * fasting ldl c = or \> 80 mg/dl; * fasting tg \< 400 mg/dl. exclusion criteria: * history of a cardiovascular or cerebrovascular event or procedure (eg, mi, stroke, tia, angioplasty) during the past year. * poorly controlled type 1 or type 2 diabetes mellitus. * poorly controlled hypertension. * fasting triglycerides \> 400 mg/dl * 12 lead ecg demonstrating qtcff \>455 msec at screening.

Keywords: hypercholesterolemia dyslipidemia high cholesterol ldl antibody pcsk9 pf-04950615 rn316
effect of probucol and/or cilostazol on mean imt in patients with coronary heart disease

Conditions: Hyperlipidemias

Summary: the purpose of this study is to evaluate the additional effect of probucol or concomitant administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean imt) at year 1, 2, and 3.

hyperlipidemic patients who are currently receiving hmgcoa reductase inhibitors(statins) will be randomized group a(control), group b(probucol only added group) or group c(probucol and cilostazol added group) . randomization will be done by the minimization method, controlling for the following factors: country(korea vs china) and max imt (≥2.0mm vs.\<2.0mm). group a : hmgcoa reductase inhibitor continued group b : hmgcoa reductase inhibitor continued + probucol 250 mg po, bid group c : hmgcoa reductase inhibitor continued + probucol 250 mg po, bid +cilostazol 100 mg po, bid

Eligibility criteria:
inclusion criteria: * 1) subjects who are at least 20 y of age at the time of informed consent (male or female) * 2) subjects with coronary heart disease longer than 3 months. * 3) subjects being treated with hmgcoa reductase inhibitors(statins) * 4) subjects with an max imt equal to or greater than 1.2 mm * 5) subjects with an ldl-cholesterol less than 200mg/dl * 6) subjects whose voluntary written informed consent is obtained for participation in this study exclusion criteria: * 1) subjects who took probucol within 6 months before participation of the study * 2) subjects who took cilostazol within 3 months before participation of the study * 3) subjects with a history of hypersensitivity to probucol or cilostazol * 4) subjects with homozygous familial hyperlipidemia\* * 5) subjects with a triglyceride ( tg) level greater than 400mg/dl at screening * 6) subjects with uncontrolled diabetes : hba1c level greater than 9% * 7) subjects with new york heart association (nyha) classification: class ⅲ and ⅳ * 8) subjects with a qtc interval greater than 450msec(male) 470msec(female) * 9) subjects with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole) * 10) subjects with atrial fibrillation (including paroxysmal af) * 11) subjects with unstable angina * 12) subjects with liver and kidney functions that satisfy the following criteria - ast or alt \>100 iu/l, serum creatinine \>1.5 mg/dl * 13) subjects who are participating in another clinical trial * 14) subjects with pregnant or possibly pregnant without appropriate contraception control. appropriate contraception control means that oral contraception for greater than 4 weeks, surgical contraception including loop insertion, condom use etc. women who has no possibility of pregnancy because of surgery or menopause should not be regarded the subject with possibly pregnant * 15) subjects with clinically significant disorders of blood coagulation * 16) subjects who are not considered by the physicians to be appropriate to participate in this trial for any other reason

Keywords: hyperlipidemias hydroxymethylglutaryl-coa reductase inhibitors probucol cilostazol